CATHETER-GUIDED REPLACEMENT VALVES APPARATUS AND METHODS

• US 20160030171A1
• Filed: 03/15/2014
• Published: 02/04/2016
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: NaviGate Cardiac Structures, Inc.
• Inventors: Quijano, Rodolfo C., Clark, Jason K.
• Granted Patent: US 10,076,410 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: H02M 1/08 Circuits specially adapted for the generation of control voltages for semiconductor devices incorporated in static converters
• CPC Class Codes: H02M 3/33592 having a synchronous rectifier circuit or a synchronous freewheeling circuit at the secondary side of an isolation transformer
• CPC Class Codes: H03K 5/1252 Suppression or limitation of noise or interference specially adapted for transmission systems H04B15/00, H04L25/08
• CPC Class Codes: Y02B 70/10 Technologies improving the efficiency by using switched-mode power supplies [SMPS], i.e. efficient power electronics conversion e.g. power factor correction or reduction of losses in power supplies or efficient standby modes

Abstract

The present invention is a replacement mitral valve suitable for catheter-based deployment. The replacement mitral valve has structure and dimensions that are uniquely suited to engage the annulus surrounding the native mitral valve and to restore normal function to a diseased valve. The invention describes the structures and functions of a replacement mitral valve and methods that are adapted for minimally invasive, catheter-based deployment of the valve.

Claims

1. A bioprosthetic heart valve assembly having a geometric configuration for implantation in an annulus of the native heart valve comprising:

a. a tubular structure having an entry opening end and an exit opening at opposite ends thereof, wherein the tubular structure is comprised of an expandable stent structure comprised of a plurality of interconnected elements having a compressed configuration and an expanded configuration and wherein a plurality of the elements are comprised of winglets that extend away from the external circumferential surface of the stent in the expanded configuration;

b. a biocompatible material covering a substantial portion of an inner annular region between the entry opening and the exit opening, and

c. a value comprised of a plurality of leaflets capable of forming a fluid tight seal at the apposing edges thereof wherein the circumference of the plurality of leaflets together form a fluid tight seal about an interior of the valve assembly between the entry opening and the exit opening, wherein the tubular structure has a tapered diameter along a length thereof such that the entry opening and the exit opening have different diameters.

2. The bioprosthetic valve assembly of claim 1, wherein the circumferential portion of the leaflets is sutured to the biocompatible material.

3. The bioprosthetic valve of assembly claim 1, whereas the winglets are disposed about an inferior outer circumferential surface of the stent member.

4. The bioprosthetic valve assembly of claim 1, whereas the winglets are disposed about an superior outer circumferential surface of the stent member.

5. The bioprosthetic valve assembly of claim 1 wherein the stent member is comprised of a plurality of vertical bars having eyelets at the end thereof

6. The bioprosthetic valve assembly of claim 1, further comprising a holder affixed to the stent member in the compressed configuration.

7. The bioprosthetic valve assembly of claim 5, wherein the eyelets on reassembly engage a fixture on an interior portion of the holder.

8. The bioprosthetic valve assembly of claim 1, wherein the expandable stent and the valve are maintained in a compressed configuration in the interior of a capsular device having a sleeve covering at least a portion of an axial length of the tubular structure.

9. The bioprosthetic valve assembly of claim 8, wherein the capsular device is comprised of a plurality of sleeves having different diameters and disposed concentrically and at least one sleeve is concentric and slidable around another.

10. The bioprosthetic valve assembly of claim 1, wherein the stent structure is comprised of a first ring of winglets and a second ring of winglets spaced apart to form an annular space therebetweeen when the stent is in the expanded configuration and sized to accommodate a native annulus of an atrioventricular heart valve.

11. The bioprosthetic valve assembly of claim 10, wherein a most interior extension of the plurality of winglets is a rounded and atraumatic length of a memory metal.

12. The bioprosthetic valve assembly of claim 10, wherein a distance from the ring of winglets are disposed proximate to the inferior edge of the stent.

13. The bioprosthetic valve assembly of claim 1, wherein a holder is disposed at the distal end of a catheter and the stent member is releasably attached to a distal end of the holder and held in a configuration that is partially expanded.

14. The bioprosthetic valve assembly of claim 13, wherein stent member is releasably attached to the holder of the entry opening.

15. The bioprosthetic heart valve assembly of claim 13, wherein the stent member is releasably attached to the holder at the exit opening.